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Intestinal Microbiota and Treatment of GD

H

Harbin Medical University

Status

Unknown

Conditions

Microbiota

Treatments

Drug: Methimazole Pill
Drug: Propylthiouracil Pill

Study type

Observational

Funder types

Other

Identifiers

NCT03433352
Yunwei Wei 2017-12-23

Details and patient eligibility

About

Graves' disease is an organ-specific autoimmune disease in which both genetic predisposition and environmental factors serve as disease triggers. Many studies have indicated that alterations in the gut microbiota are important environmental factors in the development of inflammatory and autoimmune diseases. Investigators systematically performed a comparative analysis of the gut microbiota in GD patients and healthy controls and analyse the relationship between intestinal microbiota and GD drug therapy.

Full description

Graves' disease is an organ-specific autoimmune disease in which both genetic predisposition and environmental factors serve as disease triggers. Many studies have indicated that alterations in the gut microbiota are important environmental factors in the development of inflammatory and autoimmune diseases. Investigators systematically performed a comparative analysis of the gut microbiota in GD patients and healthy controls before and found that gut microbiota changed between GD patients and healthy controls.But there are few articles on the relationship between intestinal microbiota and drug treatment of GD, so Investigators explored the relationship between intestinal microflora and methimazole treatment for GD.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Aged 18 to 65 years
  • GD was clinical diagnosed and accept the standard treatment of methimazole or propylthiouracil and thyroid function returned to normal

Exclusion criteria

  • Pregnancy
  • Lactation
  • Cigarette smoking
  • Alcohol addiction
  • Hypertension
  • Diabetes mellitus
  • Lipid dysregulation
  • BMI > 27
  • Recent (< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or Chinese herbal medicine
  • History of disease with an autoimmune component, such as MS, rheumatoid arthritis, IBS, or IBD
  • History of malignancy or any gastrointestinal tract surgery

Trial design

90 participants in 3 patient groups

Control group
Description:
30 healthy volunteers were included in the healthy control group
Recrudescence group
Description:
30 GD patients who received recurrence within 2 years after treatment with Methimazole Pill or propylthiouracil pill
Treatment:
Drug: Propylthiouracil Pill
Drug: Methimazole Pill
No recrudescence group
Description:
30 GD patients who did not receive recurrence within 2 years after treatment with Methimazole Pill or propylthiouracil pill
Treatment:
Drug: Propylthiouracil Pill
Drug: Methimazole Pill

Trial contacts and locations

1

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Central trial contact

Yunwei Wei

Data sourced from clinicaltrials.gov

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